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Role of Selective Cyclooxygenase-2 Inhibitor in Acute Pancreatitis

Phase 2
Conditions
Health Condition 1: K85- Acute pancreatitis
Registration Number
CTRI/2020/10/028188
Lead Sponsor
Dr Pramod Kumar Garg
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Acute pancreatitis as defined by revised Atlanta classification.

2. The time interval from the onset of symptoms to presentation should be less than 7 days.

3. Systemic inflammatory response syndrome (SIRS) persisting for more than 24 hours.

Exclusion Criteria

1. Age less than 18 years or more than 70 years

2. Patients with Grade 2 or more organ failure as per Modified Marshallâ??s criteria.

3. Patients with a serum creatinine >1.4 mg/dl

4. Active or past history of GI bleeding or peptic ulcer disease

5. Patients with significant co-morbidity such as coronary artery disease, chronic kidney disease, cirrhosis, chronic obstructive airway disease, inflammatory bowel disease, and congestive heart failure or malignancy.

6. Patients who have history of bronchospasm, urticaria, angioneurotic edema or other allergic reactions to COX-2 inhibitors

7. Patients with evidence of chronic pancreatitis

8. Pregnancy and breast feeding

9. Failure to give consent

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Frequency of occurrence of persistent organ failure <br/ ><br>2. Deterioration in OF score by one grade <br/ ><br>Timepoint: Four weeks or discharge
Secondary Outcome Measures
NameTimeMethod
1. Change in APACHE II and SIRS scores <br/ ><br>2. Duration of ICU stay and hospital stay <br/ ><br>3. Reduction in the need for rescue analgesia <br/ ><br>4. Reduction in level of CRP and inflammatory cytokines <br/ ><br>5. Mortality within 30 days. <br/ ><br>6. Adverse event such as gastrointestinal bleed, hypersensitivity reaction, renal impairment <br/ ><br>Timepoint: Four weeks or discharge
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